J&J Changes Remicade Label To Show Lymphoma Risk

Johnson & Johnson's (JNJ) Centocor unit sent physicians a letter Thursday warning them the incidence of a blood cancer called lymphoma appears to be higher in patients who received its drug Remicade than in the normal population. Remicade belongs to a class of drugs known as anti-tumor necrosis factor, or TNF, agents that also include Amgen Inc. (AMGN) and Wyeth's (WYE) Enbrel and Abbott Laboratories' (ABT) Humira.

It is difficult to know whether or how much this class of drugs contribute to this increase in malignancies because rheumatoid arthritis and Crohn's disease are themselves associated with an increased risk of lymphoma, Centocor said. Enbrel and Humira already have similar warnings on their labels. The potential role of these drugs in the development of malignancies is not known, the new label says.

Centocor is changing the label on Remicade to reflect the warnings. The Remicade label had mentioned a higher rate of lymphoma previously, but the language was more vague. In the letter, Centocor said that the incidence in rheumatoid arthritis clinical trials was about threefold higher than for the general population. Among all completed trials, this incidence was about sixfold higher.

Centocor spokesman Michael Parks stressed that these trials are comparing the drug to the general population - not to the higher-risk patient groups that Remicade treats. "No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving Remicade; thus, caution should be exercised in considering Remicade treatment of these patients," the new label reads.

Despite that and the fact that the absolute number of lymphoma cases in clinical trials was low, Centocor felt "it is important that physicians have this information to make an informed decision while we continue to follow this issue to help better characterize the potential risk of lymphoma in the future," the company said in an accompanying statement.

On Aug. 11, Centocor warned of serious and sometime fatal side effects for people taking Remicade. The company said serious blood-related disorders including leukopenia and neutropenia have occurred and that some patients have died. The company also warned of rare cases of a neurologic disorder known as systematic vasculitis. Labels for Remicade had already warned of blood disorders and neurologic events.

Remicade was approved by the FDA in 1998. Since then, 509,000 patients have been treated with the drug worldwide. Up to 1 million Americans suffer from Crohn's disease, an inflammation of the digestive track, while more than 2 million Americans suffer from rheumatoid arthritis, or inflamed joints.